A Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Node Mapping
FILM
A Randomized, Prospective, Open Label, Multicenter Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Node Mapping
1 other identifier
interventional
180
3 countries
8
Brief Summary
This is a randomized, prospective, open label, multicenter study to assess the safety and utility of PINPOINT® Near Infrared Fluorescence Imaging (PINPOINT) in identification of lymph nodes (LN) in patients with uterine and cervical malignancies who are undergoing LN mapping.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2015
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2014
CompletedFirst Posted
Study publicly available on registry
August 6, 2014
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedResults Posted
Study results publicly available
March 25, 2019
CompletedMarch 25, 2019
March 1, 2019
1.5 years
July 29, 2014
November 19, 2018
March 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effectiveness of PINPOINT and IC2000 in the Identification of Lymph Nodes Defined as the Proportion of Confirmed Lymph Nodes Identified
To assess the effectiveness of intraoperative PINPOINT Near Infrared Fluorescence Imaging in the identification of lymph nodes in subjects with uterine and cervical malignancies who are undergoing lymph node mapping.
Day 0
Secondary Outcomes (5)
Effectiveness of PINPOINT and Blue Dye in the Identification of at Least One Lymph Node Defined as the Number of Subjects in Which at Least One Confirmed Lymph Node Was Identified With Either PINPOINT or Blue Dye
Day 0
Effectiveness of PINPOINT and Blue Dye in the Identification of Bilateral Lymph Nodes Defined as the Number of Subjects in Which Lymph Nodes Were Identified Bilaterally With Either PINPOINT or Blue Dye.
Day 0
Identification of Lymph Nodes Following Lymphatic Channels Defined as the Number of Subjects in Which Confirmed Lymph Nodes Were Identified by Following a Lymphatic Channel With Either PINPOINT or Blue Dye.
Day 0
Safety of Interstitial Injection of ICG Defined as the Number of Adverse Effects Related to ICG
Day 0 to Day 30
Anatomic Distribution of Lymph Nodes
Day 0
Study Arms (2)
Blue - PINPOINT
ACTIVE COMPARATORThe cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.
PINPOINT - Blue
ACTIVE COMPARATORThe cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.
Interventions
PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
Eligibility Criteria
You may qualify if:
- years of age or older
- Subjects with FIGO Clinical Stage I endometrial cancer undergoing minimally invasive hysterectomy with lymph node mapping.
- Subjects with FIGO Clinical Stage IA cervical cancer ≤ 2 cm in size undergoing minimally invasive hysterectomy, trachelectomy, or conization with lymph node mapping. Subjects with clinical Stage IA1 cervical cancer without lympho vascular space involvement (LVSI) and negative margins on cone biopsy are not to be included.
- Subjects with negative nodal status (N0)
- Subjects with negative metastatic involvement (M0).
You may not qualify if:
- Have had prior dissection and/or radiation in pelvis.
- Advanced cervical or endometrial cancer, T3/T4 lesions
- Diagnosis of cervical cancer with a tumor size greater than 2 cm.
- Locally advanced or inflammatory cervical or uterine cancer
- Metastatic cervical or uterine cancer.
- Known allergy or history of adverse reaction to ICG, iodine or iodine dyes.
- Known allergy or history of adverse reaction to Blue dye (Isosulfan blue) or triphenylmethane.
- Hepatic dysfunction defined as MELD Score \> 12.
- Renal dysfunction defined as serum creatinine ≥ 2.0 mg/dl.
- Subjects who have participated in another investigational study within 30 days prior to surgery.
- Pregnant or lactating subjects.
- Subjects who, in the Investigator's opinion, have any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
O'Connor Hospital
San Jose, California, United States
Lee Memorial Hospital
Fort Myers, Florida, United States
Memorial Sloan Kettering
New York, New York, United States
Duke Cancer Institute
Durham, North Carolina, United States
MD Anderson Cancer Center
Houston, Texas, United States
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
CHU de Québec - Université Laval
Québec, Quebec, Canada
Hospital HIMA San Pablo
Caguas, Puerto Rico
Related Publications (1)
Frumovitz M, Plante M, Lee PS, Sandadi S, Lilja JF, Escobar PF, Gien LT, Urbauer DL, Abu-Rustum NR. Near-infrared fluorescence for detection of sentinel lymph nodes in women with cervical and uterine cancers (FILM): a randomised, phase 3, multicentre, non-inferiority trial. Lancet Oncol. 2018 Oct;19(10):1394-1403. doi: 10.1016/S1470-2045(18)30448-0. Epub 2018 Aug 22.
PMID: 30143441DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alicia Wilton
- Organization
- Novadaq Technologies
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Frumovitz, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2014
First Posted
August 6, 2014
Study Start
December 1, 2015
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
March 25, 2019
Results First Posted
March 25, 2019
Record last verified: 2019-03